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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00397098




Registration number
NCT00397098
Ethics application status
Date submitted
7/11/2006
Date registered
8/11/2006
Date last updated
12/03/2009

Titles & IDs
Public title
Prevention of Relapse Study of SR58611A in Improved Patients With Generalized Anxiety Disorder
Scientific title
A Double-Blind Randomized Withdrawal Study Evaluating the Efficacy and Safety of SR58611A Versus Placebo in the Prevention of Relapse of Anxiety up to 1 Year in Patients With GAD Improved After 12 Weeks of Open Label Treatment With SR58611A.
Secondary ID [1] 0 0
EudraCT 2006-002253-71
Secondary ID [2] 0 0
LTE5894
Universal Trial Number (UTN)
Trial acronym
VEGA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety Disorders 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SR58611A

Treatment: Drugs: SR58611A
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary criterion is the time to relapse of anxious symptoms (in days) from randomization date defined by either:
Timepoint [1] 0 0
Primary outcome [2] 0 0
HAM-A total score = 15 confirmed at a subsequent visit 2 weeks later unless the patient drops out,or
Timepoint [2] 0 0
Primary outcome [3] 0 0
Any drop-out for lack of efficacy (according to investigator's decision),or
Timepoint [3] 0 0
Primary outcome [4] 0 0
Prescription/use of alternative or additional treatments for relief of psychiatric symptoms.
Timepoint [4] 0 0
Secondary outcome [1] 0 0
Change from baseline (V7) in:-Clinical Global Impression (CGI) Severity of Illness Score
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Hamilton Anxiety Rating Scale (HAM-A)
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
For entry into the open phase:

- Patients suffering from generalized anxiety disorder, according to Diagnostic and
Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and assessed with the Mini
International Neuropsychiatric Interview (MINI) plus Generalized Anxiety Disorder
(GAD) module.

- With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) > 20 at
V1(D-4) and V2 (D-1).

For entry into the double-blind randomized phase:

- Improved patients with HAM-A score < 11 at V7 (W12).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inpatients.

- Patients with a diagnosis of Major Depressive Disorder (DSM IV-TR) within 6 months of
screening.

- Patients with a MADRS total score > 18 at screening or baseline.

- Patients at immediate risk for suicidal behaviour.

- Patients with other current (within 6 months) anxiety disorder according to the MINI

- Patients with a lifetime history according to the MINI of: Bipolar disorder, Psychotic
disorder, Antisocial personality disorder.

- Patients with a current history according to the MINI of: Anorexia nervosa or bulimia
nervosa in the past 6 months, Alcohol or substance dependence or abuse in the past 12
months, except nicotine or caffeine dependence.

The investigator will evaluate whether there are other reasons why a patient may not
participate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2007
Sample size
Target
Accrual to date
Final
257
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
Chile
State/province [1] 0 0
Santiago
Country [2] 0 0
France
State/province [2] 0 0
Paris
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Hungary
State/province [4] 0 0
Budapest
Country [5] 0 0
Italy
State/province [5] 0 0
Milan
Country [6] 0 0
Mexico
State/province [6] 0 0
Mexico
Country [7] 0 0
Russian Federation
State/province [7] 0 0
Moscow
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to evaluate the efficacy and safety of SR58611A (350 mg BID)
compared to placebo in the prevention of relapse of anxiety, in patients with Generalized
Anxiety Disorder improved after 12 weeks of treatment with SR58611A.

The primary objective is to evaluate the efficacy of SR58611A 350mg BID compared to placebo
over a 24 to 52-week treatment period.

The secondary objective is to assess the safety and tolerability of SR58611A in patients with
GAD.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00397098
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00397098